LUTRELLE F. PARKER, ACTING COMMISSIONER OF PATENTS AND TRADEMARKS, Petitioner v. MALCOLM E. BERGY, ET AL ., LUTRELLE F. PARKER, ACTING COMMISSIONER OF PATENTS AND TRADEMARKS, Petitioner v. ANANDA M. CHAKRABARTY
No. 79-136
OCTOBER TERM, 1979
December 13, 1979
BRIEF ON BEHALF OF THE PEOPLES BUSINESS COMMISSION, AMICUS CURIAE
LEONARD S. RUBENSTEIN, Hirschkop & Grad, P.C., 108 N. Columbus Street, Alexandria, Virginia 22312
For The Peoples Business Commission :
Ted Howard, Dan Smith, Jeremy Rifkin, 1346 Connecticut Avenue, NW, #1010, Washington, DC 20036, (202) 466-2823
II. THE ISSUES PRESENTED
The issues addressed by this amicus are:
Whether genetically engineered forms of life are a "manufacture" or "composition of matter" intended by Congress to be subject to patentability within 35 U.S.C. 101.
Whether it is in the "public interest" and serves the "useful Arts" to patent living organisms.
I. INTEREST OF THE AMICUS CURIAE AND INTRODUCTION
The Peoples Business Commission (PBC) is a non-profit educational foundation incorporated in the District of Columbia. PBC develops a wide range of educational materials designed to raise public awareness of emerging economic and technological trends within the United States and the impact these trends will have on the lives of the citizens of this country.
PBC has emerged as one of the nation's leading critics of the various biological technologies known as "genetic engineering." It is the belief of PBC that the social application of genetic engineering is rapidly proceeding without due consideration or public understanding of the wide range of ecological, evolutionary, ethical, philosophical, political and economic questions inherent in any application of bio- and genetic manipulation.
Ted Howard and Jeremy Rifkin, co-directors of PBC, are co-authors of "Who Should Play God?," the largest selling book on genetic engineering. American high school and college professors are using this book as a standard text on the ethical and social implications of genetic manipulation. "Who Should Play God?" has been translated into six foreign languages, including Japanese, French and Spanish. Howard and Rifkin's articles on various aspects of genetic engineering have appeared in The Los Angeles Times, Newsday, The Progressive, The St. Louis Post Dispatch , and scores of other publications. Because of their familiarity with the social implications of genetic engineering, PBC staff members have been called upon to testify before Congressional Committees, the National Academy of Sciences, the Department of H.E.W. Ethics Advisory Board, and the Eastern Virginia State Health Agency.
The interest of the amicus herein is PBC's belief that the present cases are of critical importance to the potential development and direction of the burgeoning genetic engingeering industry. Most financial and schentific observers concur that during the coming two decades, genetic engineering technologies will have a profit potential and social impact akin to the development of transistors and computers during the past twenty years. PBC contends that a ruling in favor of life form patents in Bergy and/or Chakrabarty would serve as a precedent in a host of related areas of genetic manipulation, most particularly in the field of recombinant DNA, or "gene splicing." Such a ruling would significantly contribute to the profit potential of the genetic industry, thus generating a greater momentum in research and development of genetic engineering technologies. This, in turn, will lead to the rapid proliferation of genetic techniques in the areas of energy, agriculture, medicine, industrial processes and many other aspects of the nation's economic life.
It is PBC's contention that such a proliferation of genetically-based technologies is not in the public interest for a host of reasons. PBC believes that the ecological, evolutionary, ethical, philosophical, political and economic questions that surround that patenting of living organisms have been given insufficient consideration by the Congress, the country as a whole and the lower court in issuing its ruling in favor of such patents.
All parties have consented to the filing of this amicus by letter, the originals of which are being filed concurrently with the clerk.
III. STATEMENT OF FACTS
On March 29, 1979, the Court of Customs and Patent Appeals ruled that General Electric and Upjohn be granted the nation's first patent for genetically engineered forms of life. The General Electric life form, a Pseudomonas bacterium developed by Dr. Ananda M. Chakrabarty, contains a new combination of plasmids not previously found in nature. This microorganism produces enzymes which break down a number of the hydrocarbon components of petroleum. The Upjohn microorganism, Streptomyces vellosus , was isolated by Dr. Malcolm E. Bergy et al., and is used in a process to produce by fermentation the antibiotic lincomycin.
The two life form patents were granted under the provision of Section 101 of Volume 35 of the U.S. Code which reads: "Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor..." In ruling in favor of the patent applications of the two companies, the majority held that there was no justification for excluding an "invention" merely "because it is 'alive'." The lower court further argued that "from the standpoint of construing the patent statutes, we do not see... any sound reason for making the distinction... here between the living the dead."
The Patent and Trademark Office had refused to grant GE and Upjohn patents on living organisms because of its belief that Congress never intended that forms of life be patentable under 35 U.S.C. 101. The PTO argued that because "the number of living things is vast," the awarding of life form patents "opens an enormous range of subject matter to patentability" including "living organisms -- life itself."
The Solicitor General of the United States petitioned this Court for a writ of certiorari. On 29 October of 1979, the Court granted the Solicitor's petition for writ of certiorari in Parker v.. Bergy et al .
IV. SUMMARY OF ARGUMENT
The Solicitor General of the United States contends that the Congress of the United States never intended that living organisms, whether modified through genetic engineering or not, be patentable under 35 U.S.C. 101. We support the Solicitor on this point, and will not further argue it herein.
The arguments developed in this brief are three-fold:
1. That the single area in which Congress has specifically authorized the patenting of living organisms through legislation -- the Plant Patent Act of 1930 and the Plant Variety Protection Act of 1970 -- provides ample evidence that the patenting of any form of life (plant or otherwise) necessarily leads to certain genetic and social impacts that are not in the best interests of society or succeeding generations.
2. That the technology of genetic engineering, taken as a whole, is not in the public interest, and should not be unduly encouraged by giving unwarranted economic incentive to corporations in the field of genetic research and development through the vehicle of awarding potentially incrative patents on living organisms.
3. That if patents are granted on microorganisms there is no scientific or legally viable definition of "life" that will preclude extending patents to higher forms of life, and that, indeed, the various technologies of genetic engineering have already created a climate in which patents on higher organisms can consistently be claimed once the precedent has been set with microorganisms.
V. ARGUMENT
1. THE RELATIVELY RECENT HISTORY OF GRANTING PLANT PATENTS ILLUSTRATES THE DELETERIOUS GENETIC AND SOCIAL EFFECTS OF PATENTING LIVING ORGANISMS.
Until the March 29, 1979 Court of Customs and Patent Appeals decision awarding patents on genetically engineered microorganisms to General Electric and Upjohn, the only living organisms considered patentable under Congressional legislation were certain types of plants and seeds. The history of our national plant patenting policy serves as a backdrop to the issue now before this Court, and should be given serious consideration before any decision regarding the patenting of other living organisms is reached.
In an attempt to encourage plant breeding and the development of new types of crops with desirable characteristics, Congress passed the Plant Patent Act of 1930. This Act provides for the patenting of certain types of asexually reproduced plants. Four decades later, Congress extended this legislation with the Plant Variety Protection Act of 1970, which provides for, among other things, certificates akin to patents for certain kinds of sexually produced plants.
These acts were passed on the assumption that patents would provide the economic incentive that would lead to the production of numerous man-made plant varieties that would be of social benefit. In fact, just the opposite has taken place. According to a publication of the National Sharecroppers Fund, the genetic and social consequences of global plant patent laws pose "a serious threat to world food supplies and to the future of agriculture." n1
n1 Cary Fowler, The Graham Center Seed Directory , Rural Advancement Fund of the National Sharecroppers Fund, (Wadesboro, North Carolina: 1979).
The deleterious effects of the various plant patent laws have been three-fold:
First, the availability of plant patents has led to the systematic, and irreversible, elimination of many varieties of useful plants and crops simply because they were products of nature and thus could not be patented. Because of this basic economic fact of life, seed and grain companies encourage the world's farmers to buy their "superior" products rather than using naturally existing native strains. Convinced of the 'superior' qualities of newly bred and designed varieties of crop plants, farmers cease to grow their traditional crops. Writes Cary Fowler of the Frank Porter Graham Demonstration Farm and Training Center of Wadesboro, North Carolina, "leftover seeds of the traditional variety may be used as food for the family or their animals. In a moment's time, thousands of years of crop development and seed selection become meaningless and another variety becomes extinct." n2 Thus, as a direct result of plant patent legislation, thousands of useful varieties of plants have been eliminated from the plantetary gene pool .
n2 Id .
Second, and as a corollary to the first effect, as patentable plants have been widely propagated, and nonpatentable varieties have been eliminated, genetic diversity is lost, and monoculturing becomes the rule. Again, Fowler: "Modern agriculture needs predictability; therefore, plant breeders strive for uniformity. Plants are bred and inbred to develop the desired characteristics. The result has been the creation of new varieties that are extremely genetically limited... Where thousands of varieties of wheat once grew, only a few can now be seen. When these traditional plant varieties are lost, their genetic material is lost forever. Herein lies the danger. Each variety of wheat, for example, is genetically unique. It contains genetic 'material' not found in other varieties. If, because of genetic limitations which result from inbreeding, new varieties are no longer resistant to certain insects or diseases (conceivably even insects or diseases never before known to attack wheat), then real catastrophe could strike." n3
n3 Id .
In fact, due to the elimination of genetic diversity stemming from the patentability of certain types of plants, disaster has already struck many farmers. The monocultured sugarcane industry has nearly been wiped out twice, and the banana industry has similarly been threatened due to lack of genetic diversity. In 1970, a corn blight struck the U.S. crop. Nearly 15 percent of the nation's crop was destroyed; in some southern states the losses topped 50 percent. According to the National Academy of Sciences: "The key lesson of 1970 [the year of the corn blight] is that genetic uniformity is the basis of vulnerability to epidemics. [Today]... most crops are impressively uniform genetically and impressively vulnerable." n4 According to a National Academy of Sciences study, just one type of sweet potato produces 69 percent of our domestic crop; two varieties of dry beans yield 60 percent of our crop; three types of millet, 100 percent; 6 types of corn, 71 percent. n5 Again, the internal logic of plant patenting has led directly to the loss of genetic diversity and the reliance of societies upon dangerously inbred and frail monocrops .
n4 Committee on Genetic Vulnerability of Major Crops, Genetic Vulnerability of Major Crops , National Academy of Sciences, 1972.
n5 Committee on Germplasm Resources, Conservation of Germplasm Resources , National Academy of Sciences, 1978.
The third effect of the Plant Patent Act is not genetic, but rather social. In a report recently published by the London-based International Coalition for Development Action, "Seeds of the Earth," author P. R. Mooney outlines how plant patent legislation has made plant breeding such a lucrative endeavour that ownership of the world's basic plant food supply is increasingly being concentrated within a small number of large multinational corporations. Seventy-nine percent of the U.S. patents issued on beans have gone to just four companies, and nearly fifty once-independent seed companies have recently been acquired by corporations such as ITT, Upjohn, Purex, and so on. According to the ICDA report, these large companies build up private gene banks to which access is limited to the companies' plant breeders. Once agrain, thanks to the patent laws, the bulk of the world's food supply is now owned and developed by a handful of corporations which alone, without any public input, determine which strains are used and how. ICDA claims: "in some crops a single enterprise dominates the total world germplasm holdings." United Brands, for instance, privately possesses two-thirds of the world's banana germplasm in storage. n6
n6 P. R. Mooney, "Seeds of the Earth," International Coalition for Development Action, (London: 1979).
This three-fold trend -- the loss of genetic diversity, monoculturing of disease and pest susceptible crops, and the private manipulation of food resources that properly belong to the entire family of man -- continues unabated. In Europe, an alarming escalation of this momentum is taking place. Because living organisms such as plants change genetically in subtle ways in response to their environment, companies have been confronted with the difficulty of enforcing their patents on "products" which differ from year to year. In an attempt to reduce these problems, legislation approved by Common Market member countries will, by 1981, make thousands of plant varieties now commonly grown in Europe illegal . These varieties can no longer be grown commercially; their seeds can not be sold; backyard gardeners can be fined for growing the banned vegetables. According to Dr. Erna Bennett of the Food and Agricultural Organization of the United Nations, up to three-quarters of all vegetable varieties now grown in Europe will go extinct as a result of this legislation. "Genetic wipe-out," she says, "might well be tomorrow's greatest single problem..." n7
n7 Cary Fowler, "From Patented Seeds, Big Business Grows," Ruralamerica , September 1979.
Because of these alarming developments, the International Coalition for Development Action recommends that patent laws in all countries relating to plants should be uniformly repealed, and plants should be recognized as "resources of common heritage to all peoples." n8
n8 Mooney. See also: "To Promote the Progress of... Useful Arts," Report of the President's Commission on the Patent System (1966) at 13, 14; Gottschalk v. Benson , 409 US 63 at 72, 73.
The history of the results of the several plant patent acts clearly shows that far from leading to a multiplicity of social benefits, the patenting of plants has in fact cruelly robbed succeeding generations of their own right to a diversified, healthy and vital gene pool. We have, in effect, made an irreversible choice for all those humans yet to be born.
Because plants are the only living organisms now patentable, the above mentioned consequences of plant patenting must be seriously considered as a possible pattern that may be repeated should other forms of life be deemed patentable by this Court. The lessons so harshy learned from plant patenting are particularly applicable in the following areas of genetic engineering:
* The novel microorganisms that will be created through various genetic engineering techniques may well be, in many cases, "superburgs," that is, they will be bred or engineered in such a way that they may become the dominant form of life within their niche in the ecosystem. The General Electric Pseudomonas , for instance, is acknowledged to contain properties resulting from the combination of a number of other bacterium. Once these microorganisms are unleashed into the ecosystem, on purpose or by accident, they may out compete other forms of life because of their unique properties. This could seriously damage the vitality of the gene pool.
* The monoculturing of certain types of high-yield, but disease and pest susceptible plants, will be repeated by the genetic engineering industry through the monoculturing of "superior" microorganisms. Geneticists are currently predicting, for instance, that within the near-term future, various chemicals, hormones and drugs will be solely produced in the laboratory by genetically engineered microorganisms because such techniques are "costeffective." Thus, within the foreseeable future, the world will be dependent upon a very limited number of biological entities to produce vital medicine and chemical necessities. The monoculturing of microorganisms may well prove as deficient as that already acknowledged in food crops.